Anti-Drug Antibody analysis dominates the Gyrolab related posters
The AAPS National Biotechnology Conference, held June 8–10 in San Francisco, USA, was presented as THE pharmaceutical biotechnology meeting. The conference certainly generated a high concentration of scientists from the pharmaceutical and biotechnology industry, ready to network and find out about the latest developments in science and analysis platforms. Gyros Inc. was there with Gyrolab xP workstation and Gyrolab xPlore and we enjoyed a lot of activity at our booth, supported by five independent posters presented during the meeting. Four of these focused on Anti-Drug Antibodies (ADA):
High sensitivity and drug tolerance
Hsieh and colleagues at Merck & Co (M1053) had developed an ADA assay on the Gyrolab platform including automated acid dissociation to reduce drug interference. This reduced assay time to 1 hour compared to 1–2 days with a separate dissociation step, and the assay delivers increased sensitivity and drug tolerance compared to an MSD assay, enabling the group to detect ADA earlier in cynomolgus monkey pharmacokinetics studies.
Generic assay saves development time
Ehlinger and colleagues at Janssen Research & Development (M1040) used Gyrolab xP workstation to develop a generic drug tolerant immunogenicity assay to analyze samples from rats dosed with human IgG antibodies. Their method is robust, with high specificity, sensitivity, drug tolerance and minimal sample consumption. The method could be applied to a range of human antibody drugs, thus reducing the development time of immunogenicity assays.
Reduced reagent consumption saves costs
Researchers at Regeneron Pharmaceuticals, Inc. presented two posters. The first, headed by Elango (M1024), described the problems of finding blockers to minimize interference due to target mediated bridging that gives false positives. The sensitivity of the Gyrolab assay was well above the industry guidelines for a human ADA assay and the low consumption of expensive blocking reagents resulted in significant cost savings over alternative platforms. In the second poster from Regeneron, Hammond and colleagues (M1041) described an ADA assay to study human monoclonal antibodies in monkeys suitable for a variety of antibody therapeutics.
The remaining independent poster concerned a Gyrolab assay for the quantification of a soluble cell-surface transmembrane receptor tyrosine kinase in mouse tumorgraft plasma samples after receiving an experimental drug, and in healthy volunteers and cancer patients (Lu and colleagues, Teva Pharmaceuticals, Inc., W3069). The assay was specific and selective with acceptable linearity, accuracy and precision.
Gyros also presented a poster that demonstrated the comparability of results from Gyrolab xPlore and Gyrolab xP workstation when measuring total and active GLP-1 (Lehtonen and colleagues, Gyros, Inc., W3023).
You can read the full abstracts below and also learn more about how Gyrolab systems, combined with Bioaffy CDs and dedicated Gyrolab ADA Software, provide an efficient way of optimizing Anti-Drug Antibody analysis by downloading the Product Information Sheet ‘Gyrolab ADA Solution’.
Gyrolab related posters
W3069 - Development of an Immunoassay with Gyrolab Workstation for the Quantification of sAXL in Mouse and Human Plasma